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510(k) K230993

Device
CODA? Anterior Cervical Plate System
Applicant
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
510(k) number
K230993
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-20
Date received
2023-04-06
Regulation
888.3060
Classification name
Appliance, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alicia Kaufman
Address
375 River Park Cir. Marquette MI US 49855 49855

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWQ#

510(k), Device, Applicant table
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K252611aprevo® cervical plating systemCarlsmed, Inc.2025-12-22
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K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.2025-07-11
K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.2025-05-23
K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.2025-05-20
K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2025-04-10
K243904Elegance® Anterior Cervical plateClariance2025-01-14